CMS Sepsis Measures Spark Controversy

Measures would likely result in overtreatment, critics say

WASHINGTON -- New federal reporting requirements for treating hospitalized sepsis patients are drawing both praise and criticism from physicians who treat the condition.

"The intent of the measure is good," said Scott Weingart, MD, an emergency physician at the State University of New York at Stony Brook. "When you look at it, you could argue this is going to help, in that it will add more recognition [to the problem]. ... but it's always about not knowing the unintended consequences."

The reporting requirements, which will be implemented in October by the Centers for Medicare and Medicaid Services (CMS), define severe sepsis as "a suspected source of clinical infection, 2 or more manifestations of systemic infection (SIRS criteria), and the presence of sepsis-induced organ dysfunction." Septic shock is defined as having severe sepsis "and ... sepsis-induced hypoperfusion persisting despite adequate fluid resuscitation, or lactate >4 mmol/L."

Providers are expected to treat these patients as follows:

Measure lactate level

Obtain blood cultures prior to antibiotics

Administer broad-spectrum antibiotics

Administer 30 mL/kg crystalloid for hypotension or lactate ≥4 mmol/L

Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure ≥65)

The measure calls for both severe sepsis and septic shock patients to receive the first three procedures within their first 3 hours of care, and for septic shock patients to receive the last four procedures within 6 hours.

The National Quality Forum (NQF), which vetted the measure for CMS, noted that sepsis continues to be a big problem at many hospitals. "The national bill for sepsis [associated with] pneumonia grew twice as fast as the overall growth in hospital charges -- about a 180% increase from 1997 to 2005, accounting for over $54 billion per year," the NQF wrote. "When combined with pneumonia, sepsis is the 3rd largest consumer of Medicare, 4th largest consumer of Medicaid, and 5th largest consumer of private insurance financial resources and total hospital days."

But the problem with the new measure, Weingart said in a blog post, is that "They have re-dubbed severe sepsis to be something very different than we are used to or have read in any of the major sepsis studies ... I am still fairly desperate to know the evidence for this new definition, but I haven't found it yet. Pretty unacceptable to hold every hospital in the U.S. accountable to an arbitrary definition that has not been tested in large-scale trials."

For instance, he wrote, the definition doesn't specify that the organ dysfunction must be thought to be due to infection. "I am sure they will say, 'We have the line "sepsis-induced" in there,' but unfortunately the measure itself doesn't list your clinical feelings anywhere as an exclusion -- so that would be bunk."

Officials at Henry Ford Hospital in Detroit, where the sepsis measure was developed over a 20-year period, defended the measure's broad reach, noting that mortality from severe sepsis and septic shock was more than 40% nationally at the start of measure development.

"Even most recent studies continue to show that one in four to five patients admitted with this disease still die in the hospital," Emanuel Rivers, MD, MPH, vice chairman and research director at Henry Ford Hospital's emergency department, said in a statement to MedPage Today. "This is the highest mortality of any disease admitted to the hospital."

Christopher Seymour, MD, of the University of Pittsburgh School of Medicine, said in a phone interview that because sepsis is a syndrome, "There is no single characteristic that identifies septic patients, and that's what makes it such a challenge." However, he added, "Sepsis is under recognized and underdiagnosed, and anything we can do to promote doctors and hospitals to take better care of patients with sepsis is serving the greater good."

For instance, "There are currently large registries of patients in which researchers studied timing of antibiotics, and the evidence shows that ... for every 1-hour delay [in antibiotic administration], there is a 3-7% increase in the odds of in-hospital mortality. This is compelling data."

Seymour and colleagues recently published an article in JAMAoutlining an algorithm for treating sepsis patients. "What we've done is put together a general 'best practice' algorithm, such as an initial management approach that involves IV antibiotics, fluid bolus, assessment of severity, and reassessment ... and ultrasound to identify whether there are complicating features such as cardiac dysfunction."

Vasopressors can be given as needed -- with norepinephrine as the first choice -- and treatment can be deescalated as soon as possible once the patient is getting better, he added.

Ronald Nahass, MD, chair of the quality committee at the Infectious Diseases Society of America (IDSA), said in a phone interview that IDSA "applauds the fact that [CMS is] looking at it and trying to address it as a problem -- because it is. It has a huge cost."

However, "like any efforts to standardize practice, there are challenges, one of which is defining the population that actually has it," continued Nahass, who is an infectious disease specialist in Hillsborough, N.J. "If you make the definition broad ... you identify everyone that does have it but also some people that probably won't. It's a well-intentioned effort, but it's pretty hard to identify who has sepsis; we are concerned it might end up causing more people to be treated than should be."

For instance, he said, "the criteria frequently used [to define sepsis] are elevated temperature, some lab abnormalities, an impact on blood pressure, an alteration of how the patient may be thinking, and an alteration of the patient's breathing pattern, but those are very non-specific features ... and other health conditions that can cause people to be critically ill can mimic that. For example, pancreatitis can absolutely mimic sepsis, so you may identify people with that condition as [having] sepsis, and they really don't have it."

In general, "the metric itself, though, has to be a work in progress," Nahass said, adding that IDSA was providing comments on the measure's choice of antimicrobulation and antibiotics.

In addition to treating people for sepsis who may not actually have it, focusing all this attention on sepsis patients will naturally mean that doctors will have less time to spend with other patients, said Weingart. "We don't have a 20% reserve that's waiting for this measure to come. Something we're already doing has to be done less well in order to do better at something else ... I think if people thought of that every time they wrote a measure, we'd be a lot better off."

Nahass isn't so sure that the clinical burden will increase. "It may result in additional testing or treatment ... But measuring lactate, getting fluids, getting blood cultures -- that's going to happen anyway with people sick in the emergency department."

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